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510(k) Data Aggregation
(231 days)
ShenZhen Deliduo Medical Technology Co.,Ltd
The Electrode Pad is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limited to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.
Electrode Pad is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of Electrode Pad is first transmitted via the snap button or lead wire then transmitted to the conductive gel which is adhered to patient skin.
Electrode Pad is composed of a top cover, connector snap button or lead wire, conductive carbon film, conductive hydrogel media, and a carrier liner. The carrier liner is made of PET (polyethylene terephthalate).
Electrode Pad is non-sterile and intended for single adult patient multiple application use. The electrode pad has various shapes and sizes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Electrode Pad (K241512), focusing on the requested information.
It's important to note that the provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for an AI-powered medical device. Therefore, much of the requested information, particularly concerning AI device performance metrics, human reader studies, and detailed ground truth establishment for a test or training set, is not present in this type of document because the device is a simple "Electrode Pad" and not an AI-enabled diagnostic tool.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate comparison, standards, and specifications) | Reported Device Performance (Subject Device K241512) |
|---|---|
| Electrical Performance: | |
| Electrode Impedance per ANSI AAMI IEC 60601-2-2 | 426-635 Ω (within predicate range 415-688 Ω) |
| Lead wires test per AAMI/ANSI ES 60601-1 (Clause 8.5.2.3) | Meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1: 2005/(R)2012 And A1:2012 |
| Electrical safety per AAMI/ANSI ES 60601-1 (for lead wire) | Meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1: 2005/(R)2012 And A1:2012 |
| Material Performance: | |
| Hydrogel thickness | 0.75±0.15mm (Similar to predicate's 1.0mm±0.2mm) |
| Stainless Steel Adhesion (180° peel) | 136 grams minimum (≈1.3N) (Same as predicate) |
| Biocompatibility: | |
| Cytotoxicity (ISO 10993-5) | Complies with ISO 10993-5:2009 |
| Skin Sensitization (ISO 10993-10) | Complies with ISO 10993-10:2010 (predicate) / ISO 10993-10:2021 (subject device) |
| Irritation (ISO 10993-23) | Complies with ISO 10993-23:2021 |
| Shelf Life/Aging: | |
| Accelerated aging (ASTM F1980-16) | Tested to ensure 2 years shelf life (Same as predicate) |
| Sterilization: | |
| Non-sterile | Non-sterile (Same as predicate) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes performance testing for a non-AI hardware device (an electrode pad). Therefore, the concept of a "test set" in the context of machine learning, with associated data provenance, is not applicable here. The tests conducted are non-clinical, laboratory-based tests on the physical device components and batches of manufactured electrodes. The document does not specify general "sample sizes" for all tests, but implies testing was sufficient to meet standard requirements. The provenance of the data is from the manufacturer's internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this is a physical medical device, not an AI diagnostic tool, there is no "ground truth" derived from expert interpretation for a test set. Acceptance is based on meeting technical specifications and international standards.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is an electrode pad, not an AI system. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical electrode pad, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is defined by:
- International Standards: Adherence to standards like ISO 10993 series for biocompatibility, ASTM F1980-16 for accelerated aging, and AAMI/ANSI ES 60601-1 / IEC 60601-2-2 for electrical safety and impedance.
- Predicate Device Specifications: Demonstrating performance within ranges or equivalent to a legally marketed predicate device (K182111 DL Adhesive Electrode) for key parameters such as impedance and adhesion.
- Design Specifications: The device met its own design specifications.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/machine learning device. The concept of a "training set" is irrelevant in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/machine learning device and therefore has no "training set" or corresponding ground truth establishment.
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